US regulator to review submission for Alkindi
A US regulatory submission from British specialty drugmaker Diurnal (AIM: DNL) for Alkindi (hydrocortisone) has been accepted for review by the Food and Drug Administration.
The firm is bidding to market the option as a replacement therapy of adrenal insufficiency (AI) for children up to the age of 17.
The application for Alkindi Sprinkle was submitted in November 2019, and the target action date for the review has been set for September 29, 2020.
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